Medicines (Finished Pharmaceutical Products/Biotherapeutic products) - Prequalification
- "+" means co-packaged product while “/” means fixed dose combination
- [A/B] + C means A and B are in a fixed-dose formulation and C is co-packaged
- For information about the listing of prequalified products and the alternative listing procedure, please see: General Information
- Some products prequalified via abridged assessment may have different storage conditions and shelf life from those accepted by the reference authority. For more information, see WHOPAR part 1.
- In product details page, the FPP sites that are used only for primary packaging are listed under “FPP Packaging only” section.
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| WHO Reference Number | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing Sort descending | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| CV014 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Aurobindo Pharma Ltd | Capsules, hard | Prequalification - Full | |
| CV016 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Zhejiang Huahai Pharmaceutical Co. Ltd. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| TB392 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Labs Pvt. Ltd. | Tablet | Prequalification - Full | |
| MA176 | Primaquine (phosphate) Tablet, Film-coated 15mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP033 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30 mg | Finished Pharmaceutical Product | Hepatitis B and C | Zydus Lifesciences Limited | Tablet, Film-coated | Prequalification - Full | |
| HP034 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60 mg | Finished Pharmaceutical Product | Hepatitis B and C | Zydus Lifesciences Limited | Tablet, Film-coated | Prequalification - Full | |
| NT017 | Miltefosine Capsules, hard 50mg | Finished Pharmaceutical Product | Neglected tropical diseases | Zydus Lifesciences Limited | Capsules, hard | Prequalification - Full | |
| NT013 | Praziquantel Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Merck Healthcare KGaA | Tablet, Film-coated | Prequalification - Full | |
| RH093 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Placebo Tablet, Film-coated 30mcg/150mcg + 0mg | Finished Pharmaceutical Product | Reproductive health | Renata Ltd | Tablet, Sugar coated + Tablet, Film-coated | Prequalification - Full | |
| TB405 | Isoniazid Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | S Kant Healthcare Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA189 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 76.5mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA190 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 153mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA191 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.50mg/250mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA192 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA769 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA193 | Pyrimethamine/Sulfadoxine Tablet 25mg/500mg | Finished Pharmaceutical Product | Malaria | S Kant Healthcare Ltd | Tablet | Prequalification - Full | |
| CV022 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Mylan Laboratories Limited | Capsules, hard | Prequalification - Full | |
| MA194 | Artesunate Powder for solution for injection 120mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Powder for solution for injection | Prequalification - Full | |
| HA787 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA782 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Reyoung Pharmaceutical Co., Ltd. | Tablet | Prequalification - Full | |
| HA783 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Reyoung Pharmaceutical Co., Ltd. | Tablet | Prequalification - Full | |
| CV023 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. | Capsules, hard | Prequalification - Full | |
| CV019 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Capsules, hard | Prequalification - Full | |
| TB393 | Rifapentine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA786 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 212579c USFDA | Atazanavir (sulfate) Capsules, hard 300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Capsules, hard | Alternative Listing | |
| EMA Art 58 H-W-2319-3 | Artesunate/Pyronaridine (phosphate) Granules for Oral suspension 20mg/60mg | Finished Pharmaceutical Product | Malaria | Shin Poong Pharmaceutical Co Ltd | Granules for Oral suspension | Alternative Listing | |
| ANDA 078850a USFDA | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Alternative Listing | |
| EMA Art 58 H-W-002168 | Dapivirine Vaginal ring 25mg | Finished Pharmaceutical Product | HIV/AIDS | International Partnership for Microbicides Belgium (IPM Belgium) AISBL | Vaginal ring | Alternative Listing | |
| ANDA 078064c USFDA | Efavirenz Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Capsules, hard | Alternative Listing | |
| ANDA 077950 USFDA | Abacavir (sulfate) Solution, Oral 20mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Solution, Oral | Alternative Listing | |
| ANDA 091475 USFDA | Lamivudine Solution, Oral 10mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Alternative Listing | |
| NDA 207369 USFDA | Abacavir (sulfate)/Lamivudine Tablet 60mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| ANDA 078064b USFDA | Efavirenz Capsules, hard 200mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Capsules, hard | Alternative Listing | |
| ANDA 079188 USFDA | Emtricitabine Capsules, hard 200mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Capsules, hard | Alternative Listing | |
| NDA 22097 USFDA | Lamivudine/Stavudine Tablet+Efavirenz Tablet 150mg/40mg+600mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet + Tablet | Alternative Listing | |
| ANDA 208355 USFDA | Dolutegravir (sodium) Tablet 50mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| NDA 205508 USFDA | Atazanavir (sulfate)/Ritonavir Tablet 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| ANDA 091611b USFDA | Atazanavir (sulfate) Capsules, hard 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Capsules, hard | Alternative Listing | |
| ANDA 078545 USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| EMA Art 58 H-W-002320 | Fexinidazole Tablet 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Sanofi-aventis groupe | Tablet | Alternative Listing | |
| ANDA 078785b USFDA | Atazanavir (sulfate) Capsules, hard 200mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Capsules, hard | Alternative Listing | |
| NDA 209618 USFDA | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet, Film-coated | Alternative Listing | |
| NDA 22177 USFDA | Lamivudine/Nevirapine/Stavudine Tablet 150mg/200mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet | Alternative Listing | |
| ANDA 078742 USFDA | Abacavir (sulfate) Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| ANDA 078929 USFDA | Lamivudine/Zidovudine Tablet 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| ANDA 077464a USFDA | Lamivudine Tablet 150mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 077521 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 200196 USFDA | Atazanavir (sulfate) Capsules, hard 300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Capsules, hard | Alternative Listing | |
| ANDA 090647 USFDA | Tenofovir disoproxil fumarate Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing |
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